Dataset Information

Outcome measures in coeliac disease trials: the Tampere recommendations.

ABSTRACT:

Objective

A gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures.

Design

Based on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-clinical outcome measures. We then made expert-based recommendations for use of these outcomes in coeliac disease trials and identified areas where research is needed.

Results

We comment on the use of histology, serology, clinical outcome assessment (including patient-reported outcomes), quality of life and immunological tools including gluten immunogenic peptides for trials in coeliac disease.

Conclusion

Careful evaluation and reporting of outcome measures will increase transparency and comparability of coeliac disease therapeutic trials, and will benefit patients, healthcare and the pharmaceutical industry.

SUBMITTER: Ludvigsson JF

PROVIDER: S-EPMC6204961 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Publications

Outcome measures in coeliac disease trials: the Tampere recommendations.

Ludvigsson Jonas F JF Ciacci Carolina C Green Peter Hr PH Kaukinen Katri K Korponay-Szabo Ilma R IR Kurppa Kalle K Murray Joseph A JA Lundin Knut Erik Aslaksen KEA Maki Markku J MJ Popp Alina A Reilly Norelle R NR Rodriguez-Herrera Alfonso A Sanders David S DS Schuppan Detlef D Sleet Sarah S Taavela Juha J Voorhees Kristin K Walker Marjorie M MM Leffler Daniel A DA

Gut 20180213 8

<h4>Objective</h4>A gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures.<h4>Design</h4>Based on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-cli ...[more]

PMID: 29440464

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Project description:BackgroundDupuytren's disease of the hand is a common condition affecting the palmar fascia, resulting in progressive flexion deformities of the digits and hence limitation of hand function. The optimal treatment remains unclear as outcomes studies have used a variety of measures for assessment.MethodsA literature search was performed for all publications describing surgical treatment, percutaneous needle aponeurotomy or collagenase injection for primary or recurrent Dupuytren's disease where outcomes had been monitored using functional measures.ResultsNinety-one studies met the inclusion criteria. Twenty-two studies reported outcomes using patient reported outcome measures (PROMs) ranging from validated questionnaires to self-reported measures for return to work and self-rated disability. The Disability of Arm, Shoulder and Hand (DASH) score was the most utilised patient-reported function measure (n=11). Patient satisfaction was reported by eighteen studies but no single method was used consistently. Range of movement was the most frequent physical measure and was reported in all 91 studies. However, the methods of measurement and reporting varied, with seventeen different techniques being used. Other physical measures included grip and pinch strength and sensibility, again with variations in measurement protocols. The mean follow-up time ranged from 2 weeks to 17 years.ConclusionsThere is little consistency in the reporting of outcomes for interventions in patients with Dupuytren's disease, making it impossible to compare the efficacy of different treatment modalities. Although there are limitations to the existing generic patient reported outcomes measures, a combination of these together with a disease-specific questionnaire, and physical measures of active and passive individual joint Range of movement (ROM), grip and sensibility using standardised protocols should be used for future outcomes studies. As Dupuytren's disease tends to recur following treatment as well as extend to involve other areas of the hand, follow-up times should be standardised and designed to capture both short and long term outcomes.

Dataset Information

Outcome measures in coeliac disease trials: the Tampere recommendations.

Objective

Design

Results

Conclusion

Publications

Outcome measures in coeliac disease trials: the Tampere recommendations.

Similar Datasets

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